An interventional study of A novel cancer-specific high energy high protein medical nutrition solution and A commercially available isocaloric isonitrogenous medical nutritional solution. in Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by Nutricia Research. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Nutricia Research (part of Danone) · Not applicable, Interventional, and Supportive care
The HEXCARE-PDAC study is a Phase III, randomized, double-blind, controlled, multicenter trial evaluating the effectiveness of a cancer-specific oral nutritional supplement in preserving skeletal muscle mass and improving chemotherapy tolerance in adults with non-metastatic pancreatic ductal adenocarcinoma (PDAC) receiving neoadjuvant FOLFIRINOX-based chemotherapy. The study aims to determine whether targeted nutritional intervention can mitigate cancer-associated muscle loss and improve treatment delivery and clinical outcomes in patients with PDAC
Nutricia Research is the lead sponsor of 51 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
The test product is a food for special medical purposes (FSMP), it is a novel cancer-specific high energy high protein medical nutrition solution.
Dietary Supplement: A novel cancer-specific high energy high protein medical nutrition solution
The control product is a commercially available isocaloric isonitrogenous medical nutritional solution.
Dietary Supplement: A commercially available isocaloric isonitrogenous medical nutritional solution.
Dietary Supplement
Dietary Supplement
Skeletal Muscle Index
The primary outcome parameter is the difference between test and control group in the mean change from baseline to the end of neoadjuvant chemotherapy in skeletal muscle mass, expressed as skeletal muscle index (SMI) \[cm2/m2\] as measured with a CT scan on the third lumbar vertebra (L3) level as skeletal muscle area (SMA) \[cm2\] corrected for height \[m\].
Time frame: From enrollment to the end of intervention at 12 weeks, max product intake up to 28 weeks
Cumulative Relative Dose Intensity
The key secondary outcome parameter is the difference between test and control group in the mean Cumulative Relative Dose Intensity (cRDI) of FOLFIRINOX or mFOLFIRINOX assessed at the end of neoadjuvant chemotherapy \[%\].
Time frame: From enrollment to the end of intervention at 12 weeks, max study product intake up to 28 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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